The FDA’s Arthritis Advisory Committee is taking up Chemocentryx Inc.’s avacopan, a complement C5a receptor inhibitor for anti-neutrophil cytoplasmic antibody-associated vasculitis. Assigned orphan drug status with July 7 as its PDUFA date, avacopan garnered questions in briefing documents related to the clinical program backing the application. Regulators were skeptical about “multiple variables, such as removing standard of care glucocorticoids and replacing it with avacopan,” as well as the endpoint of Birmingham Vasculitis Activity Score used in the Advocate trial and other matters. The San Carlos, Calif.-based firm’s shares (NASDAQ:CCXI) were struck hard by the reaction to the briefing documents, and trading was halted while the panel deliberates.

U.S. change of course on IP waiver facing backlash

The Biden administration’s May 5 about-face on the proposed TRIPS waiver of intellectual property (IP) protections for COVID-19-related medical products is not playing well with U.S. industry and others concerned about the long-term unintended consequences. Of major concern is the potential for other countries, especially China and Russia, to expropriate U.S. technology that has use beyond COVID-19 and then develop it to compete against American companies and workers in the future. There’s also skepticism that the waiver will provide immediate relief. "Handing needy countries a recipe book without the ingredients, safeguards and sizable workforce needed will not help people waiting for the vaccine,” Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), said. “Handing them the blueprint to construct a kitchen that – in optimal conditions – can take a year to build will not help us stop the emergence of dangerous new COVID variants.”

Giant steps: Dyno closes $100M series A round for advanced capsid engineering

The allocation of capital to the build-out of next-generation gene therapies continues apace. Dyno Therapeutics Inc., a leader in applying artificial intelligence to advanced capsid engineering, raised $100 million in a series A round to fund its expansion and that of its Capsidmap platform. The Cambridge, Mass.-based firm, which was founded in late 2018 and which had previously raised just $9 million in seed financing, has already carved out a distinctive profile, based on its ability to develop machine learning algorithms to guide the design of large-scale synthetic libraries of adeno-associated virus vectors and to interrogate the resulting capsids, in order to identify those with enhanced properties.

Sporos Bioventures leads a group of four entities with a $38.1M series A

Sporos Bioventures LLC, of Houston, closed a $38.1 million series A financing to develop a pipeline of therapies to treating cancer and immune diseases. The company is composed of four entities, each founded on a therapy with a different mechanism of action. Tvardi Therapeutics Inc. is the most advanced of the four as it has TTI-101, a small-molecule inhibitor of STAT3 for treating hepatocellular carcinoma and gastrointestinal cancer, in a phase I trial. Sporos’ founding chief financial officer is Michael Wyzga, who was chief financial officer and executive vice president at Genzyme Corp. for a dozen years.

Moderna, Molecular Partners report progress against SARS-CoV-2 variants

Amid what Moderna Inc. called "overwhelming" demand from global governments for mRNA vaccines and boosters effective against SARS-CoV-2 variants of concern, the company said both its authorized vaccine, mRNA-1273, and a strain-matched candidate, mRNA-1273.351, increased neutralizing titers against the variants. In response, the company increased its 2021 supply forecast. Meanwhile, Molecular Partners AG reported that in vitro studies of ensovibep, its Novartis AG-partnered COVID-19 antiviral candidate, maintained full potency against the known mutations of SARS-CoV-2, putting it on track for global phase II and III studies starting this month.

Australian biotechs Imagion and Patrys collaborate to better diagnose brain cancer

PERTH, Australia – Imagion Biosystems Ltd. has entered a collaborative research program with therapeutic antibody development company Patrys Ltd. to combine their technologies to target brain tumor imaging and diagnosis. The collaboration pairs the targeting specificity of Patrys’ deoxymabs with the imaging capabilities of Imagion’s Magsense technology to provide a better imaging agent with high specificity for hard-to-diagnose cancers such as brain cancer.

European Commission floats broad framework for regulation of artificial intelligence

The European Commission posted a draft legislative framework for regulation of artificial intelligence (AI), a document that spans all potential uses of such algorithms rather than just medical ones. The text seems to suggest that all medical uses of AI will be deemed high-risk uses, but this draft is just the opening salvo in a process that will span a year, perhaps longer, before the legislation will be drafted and finalized.

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